ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

067427

Study information

Scientific title

Acronym

COGSCHIZ

Study hypothesis

1. Does successful treatment of symptoms of schizophrenia produce measurable changes at the brain level? 2. Are there brain predictors of the clinical response to cognitive behaviour therapy in schizophrenia?

Please note that as of 19/01/2007 the anticipated end date of this trial has now been shortened to 30/03/2007. The initial anticipated end date of your trial was 30/06/2007.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia

Intervention

Functional Magnetic Resonance Imaging (MRI) will be applied to investigate brain functions of 60 patients with schizophrenia, 30 of whom will undergo cognitive behaviour therapy. All patients will be scanned twice, 8 to 9 months apart, during a series of tasks known or likely to be sensitive to symptoms of schizophrenia.

Control data will also be obtained from 20 patients with schizophrenia who have shown a good response to their antipsychotic medication and 20 healthy subjects.

Intervention type

Phase

Drug names

Primary outcome measures

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2002

Overall trial end date

30/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a diagnosis of schizophrenia:1. Who have shown partial or complete resistance to typical or atypical drug therapy2. Are right handed3. Have no history of neurological conditions or head injury4. Can tolerate scanning5. Can provide written consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Evidence of primary drug or alcohol abuse or consumption of alcohol or street drugs within 24 hours of scheduled testing.